Merck & Co. has entered into a procurement agreement, worth up to $1.2 billion, with the US government for molnupiravir, its investigational oral antiviral agent for treating mild-to-moderate COVID-19.

Molnupiravir is currently being evaluated in a Phase III clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company.

Through the agreement, if molnupiravir receives emergency use authorization (EUA) or approval by the US Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the US government. Merck has been investing at risk to support development and scale up production of molnupiravir and expects to have more than 10 million courses of the drug available by the end of 2021.

Merck also plans to submit applications for emergency use or approval to regulatory bodies outside of the US and is currently in discussions with other countries interested in advance purchase agreements for molnupiravir. Merck says it is committed to providing timely access to molnupiravir globally and intends to implement a tiered-pricing approach based on World Bank data that recognizes countries’ relative ability to finance their public health response to the pandemic.

As part of its access strategy, Merck has also entered into non-exclusive voluntary licensing agreements for molnupiravir with generics manufacturers to accelerate availability of molnupiravir in 104 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

In addition to developing molnupiravir, Merck is collaborating with Johnson & Johnson to support the manufacture of J&J’s COVID-19 vaccine.

Source: Merck & Co.